Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 360 - 379)



  360. Finally, how would you assess and what weighting would you give to patients' experiences of particular treatments, particularly when their experience of a treatment conflicted directly with the results of RCTs?
  (Professor Barnett) With great difficulty. This is not easy. I would say, however, that we rarely, if ever, hear from patients who have been harmed by a treatment. What we get is a lot of very positive testimonials to the quality of their experience. I can think of one example—and I will not quote the appraisal itself—in which we got 70 or 80 separate letters attesting to the quality of this particular intervention, one of which actually said, "It did me no good." Only one. So I am a bit concerned about who represents whom and what the balance of that judgment is there. I think also that we do take on board that there are differences of opinion. You raised the example about cancer and we are very concerned and have been concerned in the appraisals we have done on cancer topics, which were very complex, very difficult, about issues of quality of life, about how much life is worth having depending upon the quality in which you endure it. We have had representations from some patients and care organisations who say, "We don't want doctors to tell us what the quality of our life should be. We want extension of life irrespective of the pain and suffering that the drug may cause." Alternatively, we have heard that patients and carers do wish to be fully informed and make the decision that they are not prepared to put up with adverse effects. So we take all that into consideration. Balancing it up and getting the correct approach to it is not easy but it is the only process of its kind which is done in this way internationally.

Mr Amess

  361. I would certainly like to come in on cancer, but, before I do, you chaps seem pretty pleased with yourselves, if you do not mind me saying. Your evidence here seems to be a little bit complacent and self-congratulatory. You are shaking your head, but that is the way it comes across to me. You were budgeted for £12 million; that is rising. You have dealt with over 30 appraisals; you have given the green light to six and the rest you have given some restriction in. But, before coming on to cancer, the thing I want to ask you is: Do you think that the National Institute for Clinical Excellence is actually working for patients?
  (Professor Sir Michael Rawlins) Yes, I do. I think it has already enabled thousands of patients to have access to treatments that they would not otherwise have had. When we started off there was this ugly phenomenon of post-code prescribing, which was accidental, not deliberate, nobody's particular fault, but it was a scar on the health service. It was loathed by the public, it was loathed by patients and it was loathed by health professionals. The prospect of having two patients side by side in a hospital ward, one having one treatment and one another because one health authority would not pay for that particular form of treatment was just impossible. To stand on the Tyne Bridge and have access to Alzheimer's drugs north and no access south is not tolerable in a national health service. If we have done something to eradicate that very unfortunate practice, I actually do feel quite pleased and quite proud—and I think rightly so. As the time goes on, we hope that NICE will not only make sure that there is access to treatments but also that the quality of care that we can give as health professionals for patients is improved. This is not a weakness of the health service. I do not want to go away with this as another health service problem. Every health care system in the world is struggling with the problem of trying to improve the quality of care using known effective forms of treatment for their patients. We have a lot of discussions with the United States, who have three times as much money to spend per person on health care and who actually in very many respects have just as poor quality for their patients as we do, and there is a global initiative going on to try to improve the quality of care. We are part of that. We will not get there quickly but we very much hope to shift the whole median of quality of care. I am sorry if we sound arrogant. We have goals. We have not begun to meet many of them, but we have goals and aspirations and a vision for which we are quite proud.

  362. Thank you. That is a very clear answer. You think that patients are better off with your organisation. Let us deal with cancer specifically and I will come on to Professor Barnett's point about quality of life. Can you explain, Professor Rawlins, how your organisation reconciles the NHS cancer plan's commitment to the publication of your service guidelines on palliative and supportive care for people living with cancer in 2001 with the fact that these are now not expected for another two years, 2003? Can you explain that?
  (Professor Sir Michael Rawlins) Mr Dillon, would you like to explain?

  363. You cannot explain it?
  (Professor Sir Michael Rawlins) I can, but — perhaps you were not here when I explained at the beginning that I do not take part in the appraisals and I do not take part in the detail of the guidelines because I have to stand back and wait for appeals. I therefore, on legal advice, have to stick way back until such time as those processes are completed so it would be more appropriate for Mr Dillon to answer this.

  364. I just thought you would know something about the time delay, but never mind. Mr Dillon?
  (Mr Dillon) The whole of our guidelines programme started later than we wanted it to. The fact is, as I mentioned earlier, that when we were formed in 1999 the first staff were appointed by the Institute in July 1999. The priority as it was given to us by the Department and the Assembly was to establish the appraisal programme and that is what we did. In establishing it, it took all the resources that the Institute was able to bring together at such short notice. The guidelines programme therefore had to start later and commitments that might have been made previously about anticipated time lines were not delivered on because inevitably it took time for the Institute to be established, to get in place enough people to design the programmes which enable us to produce clinical guidelines.

  365. And you do not think it is pretty bad, this two-year delay?
  (Professor Sir Michael Rawlins) All guidelines take round about two years to construct. The guideline construction and development, whether it is done by us or whether it is done by the Agency for Health Care in Washington, or whether it is done by the Rand Institute in Los Angeles, Santa Monica, takes about two years to produce a full clinical guideline on a particular topic.

  366. Can you give us any date in 2003 when we will have the guidelines?
  (Mr Dillon) The palliative care cancer service guideline, the actual date in 2003—

  367. It would just be very helpful to the huge number of people who are interested in this subject if you could specify somewhere within the 12 months when we could expect the guidelines.
  (Mr Dillon) The information that I have just been given shows that there are two parts to the guidelines. We plan to deliver the first of those in November 2002 and the second part in July 2003.

  368. Thank you for that. Professor Barnett, you were talking about the quality of life with cancer patients. What do you think your organisation will be doing to ensure that?
  (Professor Barnett) First of all can I say that it is not my organisation. I chair the Independent Advisory Committee.

  369. I just hate using the word "NICE".
  (Professor Barnett) Fine.

  370. The National Institute for Clinical Excellence that you are associated with. Presumably you are here to support your two colleagues.
  (Professor Barnett) I am here to give evidence on what I feel we do, yes. The question again?

  371. You want me to repeat the question?
  (Professor Barnett) Please.

  372. What is this organisation actually going to do to ensure that cancer patients do enjoy some sort of quality of life?
  (Professor Barnett) What we are going to do is that the Appraisal Committee will look at what evidence there is for the way in which anti-cancer drugs do influence quality of life. What is obvious is that for the vast majority of anti-cancer drugs which are presently licensed measuring the quality of life improvement these drugs produce is not part of the licensing procedure. Many of the trials do not include quality of life estimates. Most of the patient information we get is from patients and relates to their personal experience and is a very important part of the appraisal process which enables us to try and assess the quality of life. Listening to those values and judging the balance of risks and benefits for the patients is a very important part of this process. The evidence base for that, however, is very poor and I think that the appraisal process in the way it functions at present will encourage future trials to take on this point of view and therefore produce better evidence in the future. What we have to do at present is to deal with what we have, and therefore listening to patients and assessing their quality of life interest is a very important part of our process. The Appraisal Committee, the individual members of it, take this very seriously.

  373. Finally, gentlemen, could you confirm that the National Institute for Clinical Excellence back in July 2000 published guidance about hearing aids including digital hearing aids—and you are very familiar with this because there has been an exchange already about this in the House of Commons—before an NHS bulk purchasing contract of digital hearing aids had been completed which revealed that the NHS can buy digital hearing aids for just £150. How could this august organisation provide guidance on the cost effectiveness of digital hearing aids before the price of digital hearing aids was known to the NHS? How is that possible?
  (Mr Dillon) First of all the NICE guidance was not specifically about digital hearing aids. The guidance was on advances in hearing aid technology. What we were doing was looking at the current range of hearing aids available to the NHS, for example, including programmable analogue aids. We base our calculations of cost effectiveness on the information that is available to us at the time. The information that we used in relation to any of the hearing aids was the price paid by the NHS for those aids at the time we were conducting our appraisal. We are not involved in, nor would we wish to be, any negotiations that the Department of Health has with manufacturers to supply any technology to the NHS.

Dr Taylor

  374. Can I come back to postcode rationing because this is something that is close to all our hearts? I absolutely welcome your aim to get rid of it but, as you know, you have not got rid of it anywhere near yet. One of the problems that has been raised goes under the phrase of "NICE blight", as I am sure you are aware. If we turn to some anti-cancer drugs we had an example of this over the weekend on a programme on Midlands television, which I am sure you did not see, but an eminent oncologist in Birmingham was saying absolutely clearly that for certain anti-cancer drugs which are under study by you at the moment but have not been passed he is prepared to jump up and down and make sure his health authority provides them, but people in South Staffordshire and Worcestershire—and he actually mentioned those two—do not get those drugs. We are talking about drugs that are of crucial benefit because unfortunately your study, quite understandably, takes a long time. Is there any way that you could, perhaps in partnership with the BNF, perhaps in partnership with the Drug and Therapeutic Bulletin, which are both intensely well read (even though I have retired I have got my up to date BNF because I need it), provide interim advice that would avoid this? We cannot have people in Worcestershire and South Staffordshire not getting what is of patent benefit that people in Birmingham are getting?
  (Mr Dillon) Apart from anything this underscores the advantages of early referral of technologies to the Institute. One of the things that we have been doing is to press the Department and the Assembly to refer technologies, including pharmaceuticals, to us to enable us to issue guidance to the NHS as close as possible to their point of launch into the Service, and we have been able to do that with a number, including the glitazones used for people with diabetes. That worked very well. The Service got the guidance very quickly after the drugs became available. When NICE was established the Department of Health issued guidance to NHS organisations that said that they had to use their local arrangements to make decisions about the way in which technologies that are being appraised by NICE should be used whilst the guidance is being prepared. We recently had an approach from a Director of Public Health who said that, given that they had to do this, it would be very helpful if they were to be able to get access to evidence that is being used by the Institute to undertake appraisals whilst we were doing it as it were. We have thought about this and we think it is a good idea, so again, as part of our new process, we will be publishing on our web site what we are going to call an appraisal consultation document. It is in affect the results of the Appraisal Committee's first consideration of any individual technology. Everyone will be able to see the direction and travel of the Institute's thinking. One advantage of that will be that anybody can comment on it, so we are being even more inclusive and transparent in terms of how we engage with those who have an interest in what we do than we were in the old process. We have also decided that we will be putting on our web site the assessment report that we were discussing earlier which has been prepared by the independent academic body. That will enable the NHS organisations that are attempting to get this interim fix sorted out to have access to good quality information so that they will be able to put in place an interim policy, of whatever kind they think is appropriate, whilst they are waiting for the Institute's guidance to be published.
  (Professor Sir Michael Rawlins) Can I add one other point to that? We have been playing a lot of catch-up at NICE. We have been looking at anti-cancer drugs that were first launched in 1994. This is not a tolerable situation. What we do need to do, as I said earlier, is to be proactive. We need to be starting the appraisal process a year before a drug is licensed. It is perfectly feasible to do it. The pharmaceutical industry thought we would find it very difficult but we have actually done it on a number of occasions now—12. In 10 out of the 12 there was no appeal against the decisions we reached, it worked pretty well, and in fact in at least six of them the companies have used NICE's good housekeeping seal of approval on their advertising. Whether I am happy about that I am not sure but that is another matter. We have to do it in advance; otherwise we will be getting into this wretched situation for years and years to come.

  375. A comment that other people have made is that they have welcomed some of your negative advice very much. Are there not treatments, techniques, which are still used that do not work that you could get rid of fairly quickly?
  (Professor Sir Michael Rawlins) Not all that quickly. We would have to go through the due process; otherwise we would find ourselves down at the Royal Courts of Justice in the Strand. We would have to do it very carefully but it is indeed one of the things that all of us want to do, to get rid of useless treatments or inferior treatments. That is one of the reasons again why we are so anxious to engage the Health Service in the agenda setting of NICE's programmes.

  376. You have said that you want to engage other people. The impression we got from the British National Formulary was that you did not work particularly closely with them. Is that so?
  (Professor Sir Michael Rawlins) The British National Formulary have received many of our forms of guidance in draft form, have they, Mr Dillon?
  (Mr Dillon) No. The BNF is not a formal consultee. The definition of "consultees" is representative patient and professional organisations that have a direct interest in the work that we do, and manufacturers. Having said that, the Royal Pharmaceutical Society is a consultee in our process.

  377. Should you not consider having the BNF because of its importance? It is what almost everyone carries.
  (Mr Dillon) It is whether it is better to go to the BNF or whether consulting with the representative professional bodies and the Royal Pharmaceutical Society is better targeting our requests for advice.

  378. What I think you are trying to get at are the prescribing doctors and that is what they carry, is it not?
  (Mr Dillon) They carry it but do not the professional organisations represent clinicians, and, indeed, the specialist societies that we identify as consultees?
  (Professor Barnett) I agree with you entirely, Dr Taylor. Senior clinicians carry the BNF. The BNF is an important listing of drugs that are licensed, drugs that can be prescribed, their dosage schedules, their contra indications, and it contains within it a degree of advice about when appropriately to use this medication. But they do not identify themselves and should not be acted upon or even be accepted as guidance in practice for a particular clinical situation. The guidance that the Appraisal Committee is intended to provide is a very different sort of guidance. It should be read in conjunction with the BNF, not instead of or in any other way. I feel that way myself because I carry it too. I think it is important.

  379. You have said "in conjunction". I am not convinced you are working in conjunction with them.
  (Professor Sir Michael Rawlins) I think I am right in saying that when the Royal Pharmaceutical Society respond it is often with comments from the BNF. Is that right or not?
  (Mr Dillon) Honestly I do not know whether I have seen comments that are specifically attributed to anyone within the BNF. It would be the Joint Formulary Committee I think that we would have to go to, so we would have to decide that it was appropriate that the Joint Formulary Committee of the BNF, and specifically its editor, was an appropriate consulted and represented clinicians' views. Clearly you feel strongly as a practitioner that it should be and that is obviously something that we would now have to consider.

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